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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-005396-25
    Sponsor's Protocol Code Number:D3250C00037
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-005396-25
    A.3Full title of the trial
    A Multicenter, Open-label, Safety Extension Study with Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ?2 Agonist (MELTEMI)
    Ensayo de extensión de seguridad, multicéntrico, abierto, con benralizumab (MEDI-563) en adultos asmáticos con un corticosteroide inhalado más un agonista ?2 de acción larga (MELTEMI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety Extension Study with Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus LABA
    Ensayo de extensión de seguridad con benralizumab (MEDI-563) en adultos asmáticos con un corticosteroide inhalado más LABA
    A.3.2Name or abbreviated title of the trial where available
    MELTEMI
    MELTEMI
    A.4.1Sponsor's protocol code numberD3250C00037
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namebenralizumab
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma (an illness that causes breathing difficulty) that is not fully controlled,
    so that episodes of breathing difficulty are still occuring despite the use of
    other available treatments
    Asma (una enf. que causa dificultad respiratoria) que no se controla totalmente, de modo q los episodios de dificultad resp. se siguen produciendo a pesar de la utilización de otros ttos. disponibles
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of 2 dosing regimens of benralizumab for adult patients
    Evaluar la seguridad y la tolerabilidad de 2 pautas posológicas de benralizumab en pacientes adultos
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of 2 dosing regimens of benralizumab on asthma exacerbations, and asthma-related hospitalizations and emergency room visits
    - To evaluate the pharmacodynamics and immunogenicity of 2 dosing regimens of benralizumab for adult patients
    - Evaluar el efecto de 2 pautas posológicas de benralizumab sobre las exacerbaciones del asma, así como las hospitalizaciones y visitas a urgencias relacionadas con el asma
    - Evaluar la farmacodinámica y la inmunogenia de 2 pautas de tratamiento de benralizumab en los pacientes adultos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines. 2.Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021. 3.Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of IP. 4.For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1. 5.All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
    1. Se debe obtener el consentimiento informado para la participación en el ensayo antes de que se realice ningún procedimiento relacionado con el ensayo y según las directrices internacionales y/o las directrices aplicables de la Unión Europea.
    2. Pacientes mujeres y varones que hayan completado al menos 16 y no más de 40 semanas en el ensayo D3250C00021.
    3. Las mujeres en edad fértil (MEF) deben aceptar el uso de un método anticonceptivo eficaz a lo largo de todo el ensayo y durante 16 semanas tras la última dosis de PEI.
    4. Solo para MEF: Deben hacerse una prueba de embarazo en orina antes de la administración de PEI en la vista 1.
    5. Todos los pacientes varones que sean sexualmente activos deben acceder a usar un método anticonceptivo de doble barrera (preservativo con espermicida) desde la primera dosis de PEI hasta 16 semanas tras la última dosis.
    E.4Principal exclusion criteria
    1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:Affect the safety of the patient throughout the study; Influence the findings of the study or their interpretations; Impede the patient?s ability to complete the entire duration of study. 2. A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy. 3. Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient?s ability to complete the entire duration of the study. 4. Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded). 5.Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP. 6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1. 7. Planned major surgical procedures during the conduct of the study. 8. Previous participation in the present study. 9. Concurrent enrolment in another drug-related interventional clinical trial. 10. AstraZeneca staff involved in the planning and/or conduct of the study. 11. Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals. 12. Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor. 13. Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved (see Section 7.1.3.1)
    1. Cualquier trastorno, incluidos entre otros cardiovascular, gastrointestinal, hepático, renal, neurológico, musculoesq., infeccioso, endocrino, metabólico, hematológico, psiquiátrico o impedimento físico importante que no sea estable en opinión del invest. y que podría: Afectar la seguridad del paciente a lo largo del ensayo. Influir en los hallazgos del ensayo o en sus interpretaciones. Impedir la capacidad del pac. para completar la duración total del ensayo.
    2. Una infección parasitaria por helmintos diagnosticada durante un ensayo precedente que ha necesitado hospitaliz., no ha sido tratada, se ha tratado de forma incompleta o no ha respondido al tto. estándar.
    3. Cualq. cambio clínicam. significativo en la exploración física, constantes vitales, ECG, hematología, bioquímica clínica o análisis de orina durante el ensayo precedente que, en opinión del investigador, pueda poner en riesgo al paciente por su participación en el ensayo, pueda influir en los resultados del ensayo o interferir en la capacidad del paciente para completar el ensayo en su totalidad.
    4. Neoplasia maligna actual o neoplasia maligna que se desarrollara durante el ensayo precedente (no se excluirá a los sujetos que tuvieron carcinoma basocelular, carcinoma espinocelular localizado de la piel que se extirpó para su curación o carcinoma in situ del cuello uterino que ha sido tratado/curado).
    5. Ser receptor de vacunas atenuadas vivas en el plazo de los 30 días antes de iniciar el tratamiento de este ensayo, durante el periodo de tratamiento y durante 16 semanas (5 semividas) después de la última dosis de PEI.
    6. Ser receptor de inmunoglobulina o hemoderivados en los 30 días previos a la visita 1.
    7. Tener planificadas intervenciones quirúrgicas importantes durante la realización del ensayo.
    8. Participación anterior en el ensayo actual.
    9. Inclusión concurrente en otro ensayo clínico intervencional relacionado con un fármaco.
    10. Personal de AstraZeneca implicado en la planificación y/o realización del ensayo.
    11. Empleados del centro del ensayo u otras personas implicadas en la realización del ensayo o miembros de la familia inmediata de dichas personas.
    12. Pacientes con desviaciones del protocolo importantes en el ensayo precedente, a discreción del promotor.
    13. Los pacientes con acontecimientos adversos serios (AAG) continuados del primer ensayo no deben incluirse en este ensayo de extensión hasta que el AAG se haya resuelto (consulte la sección 7.1.3.1).
    E.5 End points
    E.5.1Primary end point(s)
    Number of Adverse Events/Serious Adverse Events (AEs/SAEs)
    Número de Acontecimentos Adversos/Acontecimiento Adverso Grave (AA/AAG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval
    Alrededor de 108 semanas, la duración será diferente en función del tiempo de aprobación local BLA
    E.5.2Secondary end point(s)
    - Asthma exacerbations
    - Asthma-related hospitalizations and emergency room visits.
    - Eosinophil levels
    - Anti-drug antibodies (ADA)
    - Exacerbaciones del asma
    - Hospitalizaciones y visitas a urgencias relacionadas con el asma
    - Niveles de eosinófilos
    - Anticuerpos contra el fármaco (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval
    Alrededor de 108 semanas, la duración será diferente en función del tiempo de aprobación local BLA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dos regímenes de dosificación
    two dosing regiments
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Czech Republic
    France
    Germany
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
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